Methods, systems, and devices for guiding surgical instruments using radio frequency technology

ABSTRACT

Methods, systems, and devices are provided for guiding surgical instruments using radio frequency (RF) technology. In general, the methods, systems, and devices can allow a trajectory, e.g., an angular approach, of a surgical instrument relative to a patient to be identified during use of the instrument in a surgical procedure being performed on the patient. The trajectory can be identified using a plurality of RF modules. The methods, systems, and devices can allow the trajectory to be compared to a predetermined trajectory so as to identify whether the trajectory matches the predetermined trajectory. A result of the matching can be communicated to a user of the instrument. Based on the result, the user can maintain the trajectory, e.g., if the trajectory matches the predetermined trajectory, or can adjust the trajectory to closer align the trajectory with the predetermined trajectory, e.g., if the trajectory does not match the predetermined trajectory.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.13/799,414 filed on Mar. 13, 2013, which is hereby incorporated byreference in its entirety.

FIELD

The present disclosure relates generally to methods, systems, anddevices for guiding surgical instruments using radio frequencytechnology.

BACKGROUND

Spinal fixation systems can be used in orthopedic surgery to align,stabilize, and/or fix a desired relationship between adjacent vertebralbodies. Such systems typically include a spinal fixation element, suchas a relatively rigid fixation rod or plate, extending along an axisalong which the vertebral bodies are to be positioned and coupled toadjacent vertebrae by attaching the element to various anchoringdevices, such as hooks, bolts, wires, screws, etc. The spinal fixationelement can have a predetermined contour that has been designedaccording to the properties of the target implantation site and, onceinstalled, the spinal fixation element holds the vertebrae in a desiredspatial relationship, either until desired healing or spinal fusion hasoccurred, or for some longer period of time.

Spinal fixation elements can be anchored to specific portions of thevertebra. Since each vertebra varies in shape and size, a variety ofanchoring devices have been developed to facilitate engagement of aparticular portion of the bone. Pedicle screw assemblies, for example,typically have a shape and size configured to engage pedicle bone, whichis the strongest part of the vertebrae. Such screws typically include athreaded shank configured to be threaded into a vertebra, and a headportion having a spinal fixation element receiving element, which, inspinal rod applications, is typically in the form of a U-shaped slitformed in the head for receiving the rod. A closure mechanism such as aset-screw, plug, cap, etc. can be used to lock the rod into thereceiving element of the pedicle screw. In conventional use, the shankportion of each screw is threaded into a vertebra, and once properlypositioned, a fixation rod is seated through the receiving element ofeach screw, and the rod can be locked in place by tightening the closuremechanism to securely interconnect each screw and the fixation rod.Other anchoring devices include hooks and other types of bone screws

Placement of pedicle screws in a percutaneous fashion has becomedesirable in minimally invasive approaches to the spine. This techniquegenerally relies heavily on a surgeon's clear understanding of apatient's local anatomy, as well as on accurate radiographic guidancetechnology. Generally, placement is done using a large bore needle or acannulated drill to start an initial hole for screw placement. Pediclescrews are typically threaded in alignment with the pedicle axis andinserted along a trajectory that is determined prior to insertion of thescrews. Misalignment of the pedicle screws during insertion can causethe screw body or its threads to break through the vertebral cortex andbe in danger of striking surrounding nerve roots. One or moreundesirable symptoms can easily arise when the screws make contact withnerves after breaking outside the pedicle cortex, such as dropped foot,neurological lesions, sensory deficits, and pain.

The placement of pedicle screws and other surgical implants for thespine and/or for other patient anatomies requires a high degree ofaccuracy and precision to ensure a proper trajectory for the implant.Each instrument used in the process is typically intended to be insertedalong a same trajectory to ensure proper implant placement. Conventionalsurgical procedures for inserting pedicle screws involve recognizinglandmarks along the spinal column for purposes of locating optimal screwhole entry points, approximating screw hole trajectories, and estimatingproper screw hole depth. Generally, large amounts of fluoroscopy arerequired to determine a proper pedicle screw trajectory and to monitorthe advancement of a pedicle screws through the vertebra. However, suchtechniques require prolonged radiation exposure to a patient and asurgeon, which risks undesirable effects of radiation exposure.

More technologically advanced systems such as the StealthStation®Treatment Guidance System, the FluoroNav® Virtual Fluoroscopy System(both available from Medtronic, Inc. of Minneapolis, Minn.), and relatedsystems, seek to overcome the need for surgeons to approximatelandmarks, angles, and trajectories, by assisting the surgeons indetermining proper tap hole starting points, trajectories, and depths.However, these systems are extremely expensive, require significanttraining, are cumbersome in operation, are difficult to maintain, andare not cost effective for many hospitals and other surgical centers.

Accordingly, there remains a need for improved methods, systems, anddevices for guiding surgical instruments.

SUMMARY

In one embodiment, a surgical system is provided that includes a firstradio frequency module configured to be attached to a patient at anon-movable location relative to the patient such as a bone (e.g., alateral border of a transverse process of a vertebral body), a surgicalinstrument having a second radio frequency module attached thereto, anda notification module configured to provide a notification to a user ofthe surgical instrument whether or not the surgical instrument ispositioned along a predetermined trajectory to a target site within thepatient based on a determined position of the second radio frequencymodule surgical instrument relative to the first radio frequency module.

The notification module can be configured to indicate whether or not thesurgical instrument is positioned along the predetermined trajectory ina variety of ways. For example, the notification module can beconfigured to indicate whether or not the surgical instrument ispositioned along the predetermined trajectory in at least three degreesof precision. The three degrees of precision can include the surgicalinstrument being along the predetermined trajectory, the surgicalinstrument being near but not along the predetermined trajectory, andthe surgical instrument being far from the predetermined trajectory. Foranother example, the notification module can be configured to indicatewhether or not the surgical instrument is positioned along thepredetermined trajectory using at least one of an audio signal, avibration of the surgical instrument, a light, and text. For yet anotherexample, the notification module can be configured to repeatedly providethe notification to the user so as to repeatedly provide feedback to theuser regarding whether or not the surgical instrument is positionedalong the predetermined trajectory as the surgical instrument is beingmoved relative to the patient.

The system can include a determination module configured to repeatedlydetermine the position of the second radio frequency module relative tothe first radio frequency module so as to repeatedly determine whetheror not the surgical instrument is positioned along the predeterminedtrajectory. The notification module can be configured to continuouslyprovide the notification to the user so as to continuously providefeedback to the user regarding whether or not the surgical instrument ispositioned along the predetermined trajectory.

The system can include a processor configured to be in communicationwith the first radio frequency module, the second radio frequencymodule, and the notification module, configured to determine theposition of the surgical instrument relative to the first radiofrequency module, and configured to cause the notification module toprovide the notification.

In another aspect, a surgical method is provided that includes attachinga first radio frequency module to a patient at a non-movable locationrelative to the patient, e.g., a bone, and moving a surgical instrumenttoward the patient. The surgical instrument has a second radio frequencymodule attached thereto. The method can also include determining aposition of the second radio frequency module relative to the firstradio frequency module so as to determine whether or not the surgicalinstrument is being moved along a predetermined trajectory to a targetsite within the patient, and providing a notification to a user of thesurgical instrument whether or not the surgical instrument is beingmoved along the predetermined trajectory.

The notification can be provided in a variety of ways. Providing thenotification can include indicating whether or not the surgicalinstrument is positioned along the predetermined trajectory in one of atleast three degrees of precision. The three degrees of precision caninclude the surgical instrument being along the predeterminedtrajectory, the surgical instrument being near but not along thepredetermined trajectory, and the surgical instrument being far from thepredetermined trajectory. Providing the notification can include atleast one of sounding an audio signal, vibrating the surgicalinstrument, illuminating a light, and displaying text.

The method can vary in any number of ways. For example, the method caninclude determining the predetermined trajectory by positioning thesurgical instrument at a desired trajectory angle relative to the targetsite and setting a spatial relationship between the first radiofrequency module and the second radio frequency module when the surgicalinstrument is at the desired trajectory angle as the predeterminedtrajectory. The predetermined trajectory can be reset by positioning thesurgical instrument at a second desired trajectory angle relative to thetarget site and setting a spatial relationship between the first radiofrequency module and the second radio frequency module when the surgicalinstrument is at the second desired trajectory angle as thepredetermined trajectory. For another example, the method can includedetermining the predetermined trajectory by comparing a pre-operativeimage of the patient including the target site with the location of thefirst radio frequency module within the patient. For yet anotherexample, the method can include attaching a third radio frequency moduleto the patient at another non-movable location relative to the patient,and determining the predetermined trajectory by comparing apre-operative image of the patient including the target site with thelocation of the first radio frequency module and the location of thethird radio frequency module within the patient. The target site caninclude a spinal disc level, the non-movable location can include afirst vertebra above the disc level, and the second non-movable locationcan include a second vertebra below the disc level. For another example,the notification can be continuously provided to the user so as tocontinuously provide feedback to the user regarding whether or not thesurgical instrument is being moved along the predetermined trajectory asthe surgical instrument is being moved relative to the patient. For yetanother example, the method can include repeatedly determining theposition of the second radio frequency module relative to the firstradio frequency module so as to repeatedly determine whether or not thesurgical instrument is being moved along the predetermined trajectory.The notification can be continuously provided to the user so as tocontinuously provide feedback to the user regarding whether or not thesurgical instrument is being moved along the predetermined trajectory.For another example, the method can include moving a second surgicalinstrument toward the patient. The surgical instrument can have a thirdradio frequency module attached thereto. The method can also includedetermining a position of the third radio frequency module relative tothe first radio frequency module so as to determine whether or not thesurgical instrument is being moved along the predetermined trajectory,and providing a notification to a user of the second surgical instrumentwhether or not the second surgical instrument is positioned along thepredetermined trajectory.

BRIEF DESCRIPTION OF DRAWINGS

This invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a schematic view of an embodiment of a computer system;

FIG. 2 is a schematic diagram of an embodiment a trajectorydetermination system;

FIG. 3 is a schematic diagram of an embodiment of a network systemincluding the trajectory determination system of FIG. 2;

FIG. 4 is a perspective view of an embodiment of a client terminal in anOR setting that communicates with the trajectory determination system ofFIG. 2;

FIG. 4A is a perspective view of an embodiment of a patient on a bed ina surgical setting;

FIG. 4B is a series of perspective views of a spine of the patient ofFIG. 4A;

FIG. 5 is a perspective view of another embodiment of a client terminalin an OR setting that communicates with the trajectory determinationsystem of FIG. 2;

FIG. 6 is a perspective view of an embodiment of a client terminalshowing surgical procedure data received from the trajectorydetermination system of FIG. 2;

FIG. 7 is a perspective view of yet another embodiment of a clientterminal in an OR setting that communicates with the trajectorydetermination system of FIG. 2;

FIG. 8 is a perspective view of an embodiment of attaching a radiofrequency module to a vertebra of a patient;

FIG. 9 is a perspective view showing the radio frequency module of FIG.8 attached to the vertebra;

FIG. 10 is a perspective view of an embodiment of a CT scanning machineconfigured to gather pre-operative patient image information;

FIG. 11 is a perspective view of a surgical instrument having aplurality of radio frequency modules attached thereto;

FIG. 12 is a perspective view of an embodiment of a fluoroscopy systemconfigured to gather patient image information in a surgical setting;

FIG. 13 is a perspective view of the instrument of FIG. 11 in a vicinityof the vertebra of FIG. 9 at a first trajectory relative to the spine;and

FIG. 14 is a perspective view of the instrument of FIG. 13 at a second,different trajectory relative to the spine.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention

Further, in the present disclosure, like-numbered components of theembodiments generally have similar features, and thus within aparticular embodiment each feature of each like-numbered component isnot necessarily fully elaborated upon. Additionally, to the extent thatlinear or circular dimensions are used in the description of thedisclosed systems, devices, and methods, such dimensions are notintended to limit the types of shapes that can be used in conjunctionwith such systems, devices, and methods. A person skilled in the artwill recognize that an equivalent to such linear and circular dimensionscan easily be determined for any geometric shape. Sizes and shapes ofthe systems and devices, and the components thereof, can depend at leaston the anatomy of the subject in which the systems and devices will beused, the size and shape of components with which the systems anddevices will be used, and the methods and procedures in which thesystems and devices will be used.

Various exemplary methods, systems, and devices are provided for guidingsurgical instruments using radio frequency (RF) technology. In general,the methods, systems, and devices can allow a trajectory of a surgicalinstrument relative to a patient, e.g., an angular approach of theinstrument relative to the patient, to be identified during use of theinstrument in a surgical procedure being performed on the patient. Themethods, systems, and devices can allow the trajectory to be compared toa predetermined trajectory so as to identify whether the trajectorymatches the predetermined trajectory. The predetermined trajectory caninclude an optimized trajectory of the instrument for accessing thepatient, e.g., a target site at the patient such as a bone (e.g., avertebra, a patella, etc.), a soft tissue (e.g., an anterior cruciateligament, etc.), and an organ (e.g., a stomach, a bladder, etc), at anangle effective for performance of the procedure using the instrumentand/or for the instrument safely and/or efficiently accessing the targetsite, e.g., avoiding nerves, avoiding a device previously implantedwithin the patient, passing through a minimum amount of tissue to reachthe target site, etc. A result of the matching can be communicated to auser of the instrument, e.g., a surgeon, a robotic arm handling theinstrument, a surgical assistant, etc. Based on the result, the user canmaintain the trajectory, e.g., if the trajectory matches thepredetermined trajectory, or can adjust the trajectory to more closelyalign the trajectory with the predetermined trajectory, e.g., if thetrajectory does not match the predetermined trajectory. The result canbe communicated to the user in real time with use of the instrument inthe procedure. The trajectory can thus be adjusted in real time, whichcan help allow the instrument to be efficiently and quickly advanced tothe target site and/or can help prevent the instrument from damagingtissue, impinging on a nerve, needing to be reinserted into the patient,and/or deviating from a safe approach angle. The trajectory of theinstrument can be repeatedly identified during use of the instrument inthe procedure, thereby allowing the trajectory to be repeatedly comparedwith the predetermined trajectory. The user can thus repeatedly receiveinformation regarding the trajectory as compared to the predeterminedtrajectory, thereby allowing the trajectory to be adjusted throughoutuse of the instrument should the trajectory ever stray from thepredetermined trajectory.

The trajectory can be identified using a plurality of RF modules, whichcan be relatively inexpensive, can be used with relatively small powerrequirements, and can be biocompatible so as to be able to be configuredfor safe attachment to a patient, e.g., attached to a skin surfacethereof or implanted therein. The predetermined trajectory can beidentified using at least some of the plurality of RF modules, which canfacilitate comparison of the trajectory with the predeterminedtrajectory and/or can allow the trajectory to be identified duringperformance of the surgical procedure without requiring fluoroscopyduring the surgical procedure. In robotic-assisted surgery, thepredetermined trajectory can be used to guide robotically-controlledinstrument(s) along the predetermined trajectory, which can help providevery precise positioning of the robotically-controlled instrument(s) andcan facilitate human notification and correction of any deviations ofthe robotically-controlled instrument(s) from the predeterminedtrajectory.

The systems and methods disclosed herein can be implemented using one ormore computer systems. FIG. 1 illustrates one exemplary embodiment of acomputer system 10. As shown, the computer system 10 can include one ormore processors 16 which can control the operation of the computersystem 10, such as by executing an operating system (OS), a basicinput/output system (BIOS), device drivers, application programs, and soforth. The processor(s) 16 can include any type of microprocessor orcentral processing unit (CPU), including programmable general-purpose orspecial-purpose microprocessors and/or any one of a variety ofproprietary or commercially available single or multi-processor systems.The computer system 10 can also include one or more memories 18, whichcan provide temporary storage for code to be executed by theprocessor(s) 16 or for data acquired from one or more users, storagedevices, and/or databases. The memory 18 can include read-only memory(ROM), flash memory, one or more varieties of random access memory (RAM)(e.g., static RAM (SRAM), dynamic RAM (DRAM), or synchronous DRAM(SDRAM)), and/or a combination of memory technologies.

The various elements of the computer system 10 can be coupled to a bussystem 20. As will be appreciated by a person skilled in the art, theillustrated bus system 20 is an abstraction that represents any one ormore separate physical busses, communication lines/interfaces, and/ormulti-drop or point-to-point connections, connected by appropriatebridges, adapters, and/or controllers.

The computer system 10 can also include one or more network interfaces22, one or more input/output (I/O) interfaces 24, one or more storagedevices 26, and one or more display controllers 28. The networkinterface(s) 22 can enable the computer system 10 to communicate withremote devices, e.g., other computer systems, over a network. Examplesof the network interface 22 include remote desktop connectioninterfaces, Ethernet adapters, and other local area network (LAN)adapters. The I/O interface(s) 24 can include one or more interfacecomponents to connect the computer system 10 with other electronicequipment. For non-limiting example, the I/O interface(s) 24 can includehigh speed data ports, such as universal serial bus (USB) ports, 1394ports, etc. Additionally, the computer system 10 can be accessible to ahuman user, and thus the I/O interface(s) 24 can include displays,speakers, keyboards, pointing devices, and/or various other video,audio, or alphanumeric interfaces. The I/O interface 24 can facilitatecommunication between one or more I/O units 30. A person skilled in theart will appreciate that the system 10 can be configured to communicatewith a variety of I/O units 30. Examples of input units include akeyboard, a touch screen, a mouse, a joystick, and a pointing device.Examples of output units includes a speaker, a printer, a scanner, aremovable memory, and the various other components of the system 10. Thestorage device(s) 26 can include any conventional medium for storingdata in a non-volatile and/or non-transient manner. The storagedevice(s) 26 can thus hold data and/or instructions in a persistentstate, i.e., the value is retained despite interruption of power to thecomputer system 10. The storage device(s) 26 can include one or morehard disk drives, flash drives, USB drives, optical drives, variousmedia cards, and/or any combination thereof and can be directlyconnected to the computer system 10 or remotely connected thereto, suchas over a network. The display controller(s) 28 can include a videoprocessor and a video memory, and can generate data such as imagesand/or text to be displayed on a display 12 in accordance withinstructions received from the processor 16.

The elements illustrated in FIG. 1 can be some or all of the elements ofa single physical machine. In addition, not all of the illustratedelements need to be located on or in the same physical machine.Exemplary embodiments of computer systems include desktop computers,workstations, minicomputers, laptop computers, tablet computers,personal digital assistants (PDAs), mobile phones, smartphones, and thelike.

A computer system can include any of a variety of other software and/orhardware components, including by way of non-limiting example, operatingsystems and database management systems. Although an exemplary computersystem is depicted and described herein, it will be appreciated thatthis is for sake of generality and convenience. In other embodiments,the computer system may differ in architecture and operation from thatshown and described here.

One or more software modules can be executed by the system 10 tofacilitate human interaction with the system 10. These software modulescan be part of a single program or one or more separate programs, andcan be implemented in a variety of contexts, e.g., as part of anoperating system, a device driver, a standalone application, and/orcombinations thereof. A person skilled in the art will appreciate thatany software functions being performed by a particular software modulecan also be performed by any other module or combination of modules.

FIG. 2 is a schematic block diagram of one exemplary embodiment of atrajectory determination system 100. The system 100 can includes aplurality of modules, discussed further below, which can each beimplemented using one or more computer systems of the type describedabove. The system 100 can be implemented on a single computer system, orcan be distributed across a plurality of computer systems. The system100 can also include a plurality of databases, which can be stored onand accessed by computer systems. It will be appreciated by a personskilled in the art that any of the modules or databases disclosed hereincan be subdivided or can be combined with other modules or databases.

Any of a variety of parties can access, interact with, control, etc. thesystem 100 from any of a variety of locations. For non-limiting example,as shown in an embodiment illustrated in FIG. 3, the system 100 can beaccessible over a network 112 (e.g., over the Internet via cloudcomputing, over a private local area network (LAN), etc.) from anynumber of client stations 114 in any number of locations such as amedical facility 116 (e.g., a hospital, an operating room (OR), anurse's station, a medical device distribution facility, a medicaldevice company, a hospital's sterilization, records, or billingdepartments, etc.), a home base 118 (e.g., a surgeon's home or office,etc.), a mobile location 120, and so forth. The client station(s) 114can access the system 100 through a wired and/or wireless connection tothe network 112. In an exemplary embodiment, at least some of the clientterminal(s) 114 can access the system 100 wirelessly, e.g., throughWi-Fi connection(s), which can facilitate accessibility of the system100 from almost any location in the world. As shown in FIG. 3, themedical facility 116 includes client stations 114 in the form of atablet and a computer touch screen, the home base 118 includes clientstations 114 in the form of a mobile phone having a touch screen and adesktop computer, and the mobile location 120 includes client stations114 in the form of a tablet and a mobile phone, but the medical facility116, the home base 118, and the mobile location 120 can include anynumber and any type of client stations. In an exemplary embodiment, thesystem 100 can be accessible by a client terminal via a web addressand/or a client application (generally referred to as an “app”).

Referring again to FIG. 2, the system 100 can include a pre-planningmodule 200, a determination module 202, and a notification module 204.Any of the pre-planning module 200, the determination module 202, andthe notification module 204 can be used independently from one anotherand can be used in combination with any one or more of the other modules200, 202, 204. Although each of the modules 200, 202, 204 is illustratedin FIG. 2 as a singular module, each of the modules 200, 202, 204 caninclude any number of component modules, e.g., one, two, three, etc.,the same or different from any of the other modules 200, 202, 204.Further, as mentioned above, it will be appreciated by a person skilledin the art that any of the modules 200, 202, 204, and any of theirvarious component modules, can be subdivided or can be combined withother modules, including modules illustrated in FIG. 2 as being indifferent ones of the modules 200, 202, 204. The system 100 can alsoinclude at least one patient RF module 212 and at least one instrumentRF module 214, which can each be configured to transmit information viaradio frequency to the system 100 that can be analyzed by one or more ofthe pre-planning module 200, the determination module 202, and thenotification module 204, as discussed further below.

The system 100 can include a pre-planning database 206 configured to beaccessible by the pre-planning module 200 and configured to storepre-planning data. The system 100 can also include a procedure database208 configured to be accessible by the determination module 202 and thenotification module 204 and configured to store procedure data. Each ofthe databases 206, 208 can include any number of component databases,e.g., one, two, three, etc., the same or different from any of the otherdatabases 206, 208. As mentioned above, it will be appreciated by aperson skilled in the art that any of the databases 206, 208, and any oftheir various component databases, can be subdivided or can be combinedwith other databases, including databases illustrated in FIG. 2 as beingin different ones of the databases 206, 208. Any portion of any of thedatabases 206, 208 can be configured to be accessed by any one or moreof the modules 200, 202, 204. Although the system 100 in the illustratedembodiment stores data in database(s), any of the systems disclosedherein can store data in database(s) and/or in other data organizationstructure(s).

The system 100 can also include a notification unit 210 configured to beaccessible by the notification module 204 and configured to provide anotification to a user of the system 100 of information related toperformance of a surgical procedure on a patient. Although thenotification unit 210 is illustrated in FIG. 2 as a singular unit, thenotification unit can 210 include any number of notification units,e.g., one, two, three, etc. Examples of the notification unit 210include a light, a speaker, a vibration unit, and a display.

In general, and as discussed further below, the pre-planning module 200can be configured to facilitate determination of a trajectory of asurgical instrument relative to a patient on which the surgicalinstrument is to be used in performance of a surgical procedure. Thedetermined trajectory can thus be a predetermined trajectory that isdetermined before the surgical instrument is actually used on thepatient and/or is actually advanced into the patient's body. Thepredetermined trajectory can be determined using at least the patient RFmodule(s) 212, as discussed further below. The pre-planning module 200can be configured to store the predetermined trajectory in thepre-planning database 206.

The determination module 202 can be configured to determine whether asurgical instrument being used to perform an actual surgical procedureon the patient has a trajectory relative to the patient that is alignedwith the predetermined trajectory stored in the pre-planning database206. The determination module 202 can thus be configured to compare thepredetermined trajectory with an actual trajectory so as to determine adeviance of the trajectory from the predetermined trajectory. Thedetermination module 202 can be configured to perform the comparisonusing the patient RF module(s) 212 and the instrument RF module(s) 214,e.g., using an RF positioning technique such as radio frequencyidentification (RFID) localization, RFID triangulation, RFID zoning,etc.

Based on whether the trajectory is aligned with the predeterminedtrajectory, e.g., based on the determination made by the determinationmodule 202, the notification module 204 can be configured to cause thenotification unit 210 to provide a notification indicating thealignment, or misalignment, of the trajectory with the predeterminedtrajectory. The notification can include a visual, tactile, and/orauditory indication as to whether a surgical instrument being used inperforming the surgical procedure has a trajectory relative to thepatient that is aligned with the predetermined trajectory. Thenotification can thus allow the surgical instrument's actual trajectoryto be maintained, if the trajectory aligns with the predeterminedtrajectory, or to be adjusted to more closely align with thepredetermined trajectory, if the trajectory is offset from thepredetermined trajectory. The surgical instrument can thus be morelikely to be safely and optimally used in the surgical procedure, to bequickly adjusted to an optimal angle relative to the patient, and/or tobe less likely to cause tissue damage or otherwise harm the patient byunintentionally contacting or otherwise impinging on nerves, softtissue, etc. The determination module 202 can be configured torepeatedly compare the trajectory with the predetermined trajectory suchthat as the instrument moves relative to the patient, the notificationmodule 204 can be configured to cause the notification unit 210 toprovide notification if the instrument ever veers from the predeterminedtrajectory.

It will be appreciated by a person skilled in the art that the system100 can include security features such that the aspects of the systemavailable to any particular user can be determined based on the identityof the user and/or the location from which the user is accessing thesystem. To that end, each user can have a unique username, password,and/or other security credentials to facilitate access to the system100. The received security parameter information can be checked againsta database of authorized users to determine whether the user isauthorized and to what extent the user is permitted to interact with thesystem 100, view information stored in the system 100, and so forth.Examples of parties who can be permitted to access the system 100include surgical technicians, surgeons, nurses, and operating roomdirectors.

In an exemplary embodiment, users of the system 100 can include medicalpractitioners who treat patients in an operating room (OR) or othersurgical procedure performance setting. In some embodiments, the system100 can be accessible by users other than medical practitioners, such asby medical administrators, medical students, etc. Different users canhave access to different portions of the system 100, as mentioned aboveregarding security features. For example, the system 100 can beconfigured to allow surgeons to access all of the modules 200, 202, 204and to allow other operating room personnel to access only thedetermination module 202. A user can have access to only a portion of amodule, e.g., to only a subset of component modules within any one ormore of the modules 200, 202, 204.

FIG. 4 illustrates an embodiment of a user 122 accessing the system 100in an OR via a client terminal in the form of a computer including aprocessor (not shown), a display 124, and a keyboard 126. In theillustrated embodiment, the user 122 is viewing a pre-operative image ofa patient's spine in connection with a spinal procedure being performedin the OR, e.g., disc fusion, disc removal, cage insertion, etc. Forsome spinal surgical procedures, a trajectory of lateral approach can bevery important so as to access a target vertebra while avoiding nervedamage, and a patient's position can be of particular importance to thesurgery's duration and ultimate success. During lateral interbodysurgery, for example, it can be advantageous to align a representativeplane of a superior endplate of a patient's inferior vertebra tovertical plumb, and it can be advantageous to align a mid frontal planeof the patient's interbody space to vertical plumb. In other words, itcan be advantageous to position a center of the patient's vertebraldisc, as well as endplates of the vertebrae, straight down from aperspective of a surgeon performing the surgery. Implantation of one ormore percutaneous screws while a patient remains in a lateral positionis an example of a spinal surgical procedure in which precise trajectoryand patient positioning is important. As shown in FIGS. 4A and 4B,lining up a patient's pedicle 123 for direct horizontal pedicle screwplacement can be about a 30° rotation. FIG. 4B shows the pedicle 123 inan initial position, e.g., at 30°, on the left, and in a rotatedposition, e.g., at 0° (horizontal), on the right. In an exemplaryembodiment, the system 100 can be configured to inform medical personnelof a relation of an operative instrument to the 30° trajectory, or thesystem 100 can inform the medical personnel during surgical bedpositioning of the patient's pedicle relation to horizontal. The system100 can, however, be used to simulate other types of surgical proceduresand view other data.

In an exemplary embodiment, as shown in FIG. 4, an OR has a singledisplay or user interface configured to display information from thesystem 100 for consultation during a surgical procedure performed in theOR. The display or user interface can be located in the OR, or can be ina nearby area visible from the OR. FIG. 5 illustrates an embodiment ofan OR setting in which the system 100 can be accessed via a clientterminal in the form of a computer including a processor (not shown), adisplay 128, and a keyboard 130. In the illustrated embodiment, asurgeon 132 and medical support personnel 134 can all view the display128, which can help all OR personnel be aware of information provided bythe system 100 and any other information provided on the display 128that can help the personnel track the procedure, be better informed oftheir duties, and help quickly notice any anomalies.

Various types of data gathered and/or analyzed by the system 100 duringand before a surgical procedure can be displayed on the display 128.FIG. 6 illustrates the display 128 showing examples of various types ofdata, namely three images of a surgical site captured during a surgicalprocedure at a same time from three different perspectives. Anotherportion of the display 128 (top right quadrant) shows a pre-operativepatient x-ray of the surgical site. By allowing the user to viewdifferent data simultaneously, the user can better evaluate success ofthe surgical procedure, including proper instrument trajectory angles.Different types of data can be displayed on the display 128 other thanthe information shown on the display 128, such as time durations ofcertain steps of the surgical procedure, a total time duration of thesurgical procedure, notification(s) triggered by the notification module204, pre-op images of the patient stored in the pre-planning database206, etc.

FIG. 7 illustrates another embodiment of an OR setting in which thesystem 100 can be accessed via a client terminal in the form of acomputer including a processor (not shown) and a display 136 located ata position easily seen from all or nearly all positions within the OR bya surgeon 138 and medical support personnel 140.

Although the illustrated embodiments of FIGS. 4, 5 and 7 each includeonly one display for the system 100 in an OR, any number of displays forthe system 100 can be provided in an OR. Providing a plurality ofdisplays can allow more information to be easily accessible to medicalpersonnel in the OR at any given time, can help focus medical personnelby allowing for different medical personnel to have dedicated displaysproviding information most useful for their particular job, and/or canreduce surgeon fatigue by allowing the surgeon to position themselvesdifferently than if the displays were not available. Additionally, anyone or more displays for the system 100 in the OR can be configured todisplay a plurality of views, e.g., have picture-in-picture capability(e.g., two different camera angles of the same surgical site) and/orprovide overlays of data (e.g., an illustrated trajectory line over apre-operative image of a patient's anatomy).

Various types of data gathered and/or analyzed by the system 100 can beprovided to a user of the system 100 via the notification unit 210,e.g., displayed on a display and/or otherwise made available to medicalpersonnel in the OR such as by other visual indicator (e.g., by blinkinglight on a surgical instrument, etc.), motion (e.g., by vibration of asurgical instrument, etc.), and sound (e.g., by audio beep from aspeaker, etc.). By providing non-auditory feedback alone or incombination with visual feedback, the feedback can be less likely to belost or overlooked in a noisy OR environment.

The pre-planning module 200 can generally provide users of the system100 with an interface for creating and storing data related to asurgical procedure to be performed on a patient before the surgicalprocedure is performed on the patient. In an exemplary embodiment, onlysurgeons authorized to perform surgery can access the pre-planningmodule 200, which can help ensure that a patient's pre-surgery planningremains consistent with the performing surgeon's preferences, plans,etc. The pre-planning database 206 can be configured to store datacreated and/or collected by the pre-planning module 200. The data storedin the pre-planning database 206 can be used by the determination module202 in making various determinations during and/or after performance ofan actual surgical procedure, as discussed further below.

As will be appreciated by a person skilled in the art, various types ofdata related to a patient can be gathered prior to performance of asurgical procedure on the patient and stored in the pre-planningdatabase 206. This data can be used in planning the surgical procedureand/or during performance of the surgical procedure to help the surgicalprocedure be safely and efficiently performed on the patient. Examplesof data that can be stored in the pre-planning database 206 include datarelated to the patient, such as one or more pre-operative images of atargeted area of the patient for surgery, number of the patient RFmodules 212 implanted in the patient, type of each patient RF module 212implanted in the patient, weight, medical insurance information, age,medical history of the patient, prior surgery performed on the patient,drug allergies, drug interactions, physiological data, current medicaldiagnoses, bone density, blood type, cumulative radiation exposure(e.g., a total amount of radiation the patient has been exposed tothrough x-rays and/or other radiation sources), medications currentlybeing taken by the patient, etc., and data related to surgicalpersonnel, such as an identification of which and how many medicalpersonnel are to be present in the OR at any given time, how long eachmedical personnel member is scheduled to be present during the surgicalprocedure, number of personnel changes during performance of thesurgical procedure, cumulative radiation exposure (e.g., a total amountof radiation each of the personnel members has been exposed to throughx-rays and/or other radiation sources), etc. Having a cumulativeradiation exposure amount for the patient and/or for the surgicalpersonnel can help encourage reduction of a person's radiation exposureand help ensure that the person is not exposed to radiation beyond anacceptable level within a certain period of time.

In an exemplary embodiment, at least one or more pre-operative images ofa targeted area of the patient for surgery can be stored in thepre-planning database 206. The pre-operative image(s) can include anynumber of images and can be gathered in any one or more ways, as will beappreciated by a person skilled in the art. Examples of such imagesinclude x-rays, magnetic resonance imaging (MRI) images, x-ray computedtomography (CT) scans, etc. In an exemplary embodiment, prior to takingof at least one of the pre-operative images of the patient, the one ormore patient RF modules 212 can be attached to the patient. At least oneof the pre-operative images can thus include an image of the one or morepatient RF modules 212. The pre-planning module 200 and/or thedetermination module 202 can use the pre-operative image(s) includingthe one or more patient RF module 212 therein to help pre-determine,before performance of the surgical procedure, an optimal trajectory of asurgical instrument relative to the patient and/or help determinewhether a surgical instrument being used in the surgical procedure isaligned with the optimal trajectory. As discussed further below, in someembodiments, a single one of the patient RF modules 212 can be attachedto the patient, while in other embodiments, a plurality of the patientRF modules 212 can be attached to the patient.

Each of the one or more patient RF modules 212 configured to be attachedto the patient can have a variety of sizes, shapes, and configurations.If a plurality of the patient RF modules 212 are attached to thepatient, each of the plurality of patient RF modules 212 can be the sameas or different from any one or more of the other patient RF modules212. In general, the at least one patient RF module 212 can beconfigured to be attached to a patient and to wirelessly communicateusing radio frequency electromagnetic fields, which can allow thepatient RF module(s) 212 to be queried without requiring a visual lineof sight to the patient RF module(s) 212. The patient RF module(s) 212can be configured to wirelessly transmit a signal in response to awireless signal transmitted by an external source, such as an RFcontroller 216 (e.g., a handheld RF wand or controller, an RF controllercoupled to a stationary object such as a table or a wall, etc.) Thesignal transmitted by each of the patient RF module(s) 212 can includeone or more types of data associated with the patient RF module(s) 212,such as RF-specific information (e.g., an identifier uniquelyidentifying the RF module such as an identification code or name, dateof the RF module's attachment to the patient, etc.) and/orpatient-specific information (e.g., an identifier uniquely identifyingthe patient such as an identification code or name, a type of surgicalprocedure to be performed on the patient, a timestamp and/or datestampof the RF query of the patient RF module, etc.). The data transmitted byeach of the patient RF module(s) 212 can be stored in an on-board memoryof the patient RF module(s) 212. The patient RF module(s) 212 can eachinclude an on-board power source, e.g., a battery, or can be powered byan external source. The patient RF module(s) 212 can be biocompatible soas to be configured to be safely attached to the patient. In anexemplary embodiment, the patient RF module(s) 212 can be biocompatible,can be configured to be implanted within a patient, and can lack anon-board power source. Examples of patient RF module(s) 212 include RFIDtags that include an emitter configured to emit RF signals and areceiver configured to receive RF signals. The measurement/sensing ofRelative Signal Strength of a given RFID module can be used as an analogfor target distance by comparison with known/calibrated/expected signalstrength from a target at that distance. Range finding can be performedby RF reflective or echo transmitting range finding. Other forms ofelectro-magnetic-radiation can be used for range finding, e.g.,infra-red; optical laser; non-EMR pressure wave sensors such as ultrasound sensors can be used for target ranging; etc. The known distancesfrom transmitters to targets can be combined algebraically and used forcontinuous update of the surgical instrument's position and trajectory.Using RFID tags for object position determination is further discussedin Ting et al., “The Study on Using Passive RFID Tags for IndoorPositioning,” International Journal of Engineering Business Management,Vol. 3, No. 1 (2011), pp. 9-15.

The one or more patient RF modules 212 can be attached to the patient ina variety of ways. In an exemplary embodiment, the patient RF module(s)212 can be attached to an exterior surface of the patient, e.g.,attached to the patient's skin. The patient RF module(s) 212 can beattached to the exterior surface of the patient in a variety of ways,such as by using one or more attachment elements such as a biocompatibleadhesive (e.g., a glue), medical tape, etc. Being attached to anexterior surface of the patient can facilitate temporary attachment ofthe patient RF module(s) 212 to the patient by allowing the patient RFmodule(s) 212 to be easily unattached from the patient with minimalpatient discomfort and without requiring surgery to unattach the patientRF module(s) 212.

In another exemplary embodiment, the patient RF module(s) 212 can beattached to a patient by being implanted within a patient's body. Thepatient RF module(s) 212 can be implanted in a variety of ways using avariety of surgical techniques, as will be appreciated by a personskilled in the art. The one or more patient RF modules 212 can beimplanted within the patient at a variety of locations. In an exemplaryembodiment, the one or more patient RF modules 212 can be attached to anon-movable location relative to the patient, e.g., attached to a boneor a tooth. The non-movable location can be adjacent a target surgicalsite within the patient, e.g., attached to a vertebra being operated on,attached to a vertebra next to a vertebra being operated on, attached toa femur near a reattachment site for a damaged anterior cruciateligament (ACL), etc. Attaching the patient RF module(s) 212 at anon-movable location relative to the patient can allow the patient RFmodule(s) 212 to remain at fixed position(s) relative to the targetsurgical site, even if the patient shifts position relative to a surgeonor other medical personnel, to instruments, to an operating table, etc.The patient RF module(s) 212 can thus provide consistent locationalinformation relative to the surgical site during performance of thesurgical procedure and/or as compared to pre-operative images of thepatient showing the patient RF module(s) 212 and/or showing the targetsurgical site. Implanting the one or more patient RF modules 212 canallow the implanted patient RF module(s) 212 to be used in performanceof multiple, different surgical procedures. The patient RF module(s) 212can be attached to the patient within the patient in a variety of ways,such as by using any one or more attachment elements such as abiocompatible adhesive (e.g., a glue), a pin, a screw, etc.

In some embodiments, the patient RF module(s) 212 can be implanted inthe patient during a same surgical procedure in which the patient RFmodule(s) 212 are used in determining a trajectory of a surgicalinstrument being used in the procedure. This can reduce a number ofsurgical procedures performed on the patient and/or can allow atrajectory to be predetermined for a surgical instrument being used inperforming the procedure, as discussed further below. In otherembodiments, the patient RF module(s) 212 can be implanted within thepatient in a surgical procedure prior to the surgical procedure in whichthe patient RF module(s) 212 are used in determining a trajectory of asurgical instrument being used in the procedure. This can facilitatepre-planning of the surgical procedure by allowing one or morepre-operative images of the patient having the patient RF module(s) 212implanted therein be taken outside an OR, e.g., in a non-surgicalsetting, by providing more time for a surgeon to plan the surgicalprocedure between implantation of the patient RF module(s) 212 andperformance of the surgical procedure, and allow a trajectory to bepredetermined for a surgical instrument to be used in performing theprocedure, as discussed further below.

If a plurality of patient RF modules 212 are attached to a patient, allof the patient RF modules 212 can be externally attached to the patient,all of the patient RF modules 212 can be implanted within the patient,or at least one of the patient RF modules 212 can be externally attachedand at least one of the patient RF modules 212 can be implanted.Attaching a plurality of patient RF modules 212 to the patient canfacilitate triangulation of the patient RF modules 212 with the one ormore instrument RF modules 214. In general, a greater number ofinstrument RF modules 214 corresponds to a greater accuracy oftriangulation. The triangulation can provide positional information inmultiple planes, e.g., X and Y planes to approximate a planar locationand a Z plane to indicate a depth location.

FIGS. 8 and 9 illustrate one embodiment of implanting a patient RFmodule 142 within a patient by attaching the patient RF module 142 to avertebra 144 of a spine 146 of the patient. For a lateral surgicalapproach, the patient RF module 142 can be attached to a lateral borderof a transverse process of a vertebral body, which can facilitate use ofthe patient RF module 142 in determining instrument trajectory withoutthe patient RF module 142 interfering with the lateral approach accessto the surgical site. As shown in FIG. 8, the patient RF module 142 canbe implanted by a hand 148 of a surgeon or other medical personnel. Asmentioned above, the patient RF module 142 can include one or moreattachment elements configured to facilitate attachment of the patientRF module 142 to the vertebra 144. In the illustrated embodiment, thepatient RF module 142 includes three attachment elements in the form offirst, second, and third pins 150 a, 150 b, 150 c, although the patientRF module 142 can include any number of attachment elements that caneach be the same as or different from any of the patient RF module'sother attachment elements. In the illustrated embodiment, the first pin150 a has a plurality of bone-engaging features in the form of ridgesextending circumferentially therearound along a longitudinal length ofthe first pin 150 a. The bone-engaging features can help secure thefirst pin 150 a within the vertebra 144 and help prevent the first pin150 a from backing out of the vertebra 144. Other examples ofbone-engaging features include a thread and a textured surface. Thesecond and third pins 150 b, 150 c are positioned on opposite sides ofthe first pin 150 a in the illustrated embodiment and lack bone-engagingfeatures. The second and third pins 150 b, 150 c being positioned onopposed sides of the first pin 150 a can help prevent the patient RFmodule 142 from rotating about the first pin 150 a when each of the pins150 a, 150 b, 150 c extend at least partially into the vertebra 144.Each of the first, second, and third pins 150 a, 150 b, 150 c can havepointed distal tips, as in the illustrated embodiment, which canfacilitate penetration of the first, second, and third pins 150 a, 150b, 150 c into a bone such as the vertebra 144.

FIG. 10 illustrates an embodiment of obtaining a pre-operative image ofa patient 154 using a CT scanning machine 152. However, as mentionedabove, pre-operative images of a patient can be obtained in addition toor instead of CT images, such as by using other technologies such asx-ray. FIG. 10 shows the single patient RF module 142 of FIG. 9. Thesingle RF module 142 of FIG. 9 is implanted within the patient 154 inthe illustrated embodiment and would thus be invisible from an exteriorof the patient 154 but is visibly shown in FIG. 10 for clarity ofillustration. Also, the patient RF module 142 is shown in theillustrated embodiment as being attached to the vertebra 144 in advanceof a spinal surgical procedure to be subsequently performed on thepatient 154, but as mentioned above, patient RF modules can be implantedin a variety of locations, can be attached to a variety of differentpatient anatomies, and can be used in a variety of types of surgicalprocedures. As will be appreciated by a person skilled in the art, theCT scanning machine 152 can obtain one or more images of the patient154. The one or more obtained images can be stored in the pre-planningdatabase 206. The CT scanning machine 152 can be configured to directlytransmit the one or more obtained images for storage in the pre-planningdatabase 206, or the CT scanning machine 152 can be configured toindirectly transmit the one or more obtained images for storage in thepre-planning database 206 by first transmitting the one or more obtainedimages to another device, such as a desktop computer or a serverconfigured to store the one or more obtained images in the pre-planningdatabase 206. As discussed further below, the one or more obtainedimages can be used by the pre-planning module 200 in pre-determining atrajectory of a surgical instrument to be used in performing the spinalsurgery on the patient 154 and/or can be used by the determinationmodule 202 in determining an actual trajectory of the surgicalinstrument as the instrument is being used in performing the spinalsurgery on the patient 154.

Referring again to FIG. 2, each of the one or more instrument RF modules214 can also have a variety of sizes, shapes, and configurations. If thesystem 100 includes a plurality of instrument RF modules 214, each ofthe plurality of instrument RF modules 214 can be the same as ordifferent from any one or more of the other instrument RF modules 214.In general, the at least one instrument RF module 214 can be configuredto be attached to a surgical instrument and to wirelessly communicateusing radio frequency electromagnetic fields, which can allow theinstrument RF module(s) 214 to be queried without requiring a visualline of sight to the instrument RF module(s) 214. The instrument RFmodule(s) 214 can be configured to wirelessly transmit a signal inresponse to a wireless signal transmitted by an external source, such asthe RF controller 216. The signal transmitted by each of the instrumentRF module(s) 214 can include one or more types of data associated withthe instrument RF module(s) 214, such as RF-specific information (e.g.,an identifier uniquely identifying the RF module such as anidentification code or name, date of the RF module's attachment to theinstrument, etc.) and/or instrument-specific information (e.g., anidentifier uniquely identifying the instrument such as an identificationcode or name, a timestamp and/or datestamp of the RF query of theinstrument RF module, etc.). The data transmitted by each of theinstrument RF module(s) 214 can be stored in an on-board memory of theinstrument RF module(s) 214. The instrument RF module(s) 214 can eachinclude an on-board power source, e.g., a battery, or can be powered byan external source. The instrument RF module(s) 214 can be biocompatibleso as to be configured to be safely used with the patient, although theinstrument RF module(s) 214 need not be biocompatible, such as if theinstrument RF module(s) 214 are embedded within an instrument. In anexemplary embodiment, the instrument RF module(s) 214 can bebiocompatible and can lack an on-board power source. Examples ofinstrument RF module(s) 214 include the RFID tags mentioned above withrespect to the patient RF module(s) 212.

The one or more instrument RF module(s) 214 can be attached to theinstrument in a variety of ways. In an exemplary embodiment, theinstrument RF module(s) 214 can be attached to a non-movable location ofthe instrument, e.g., not within a part of the instrument that movesrelative to another part of the instrument such as a rotatable knob, amovable lever, a translating rod, etc. In this way, the instrument RFmodule(s) 214 can be configured to remain at a fixed, predictablelocation, thereby allowing the instrument RF module(s) 214 to provideconsistent locational information. The instrument RF module(s) 214 canbe attached to a proximal portion of the instrument that is configuredto be located outside a patient's body during use of the instrument on apatient, such as in a handle of the instrument, and/or the instrument RFmodule(s) 214 can be attached to a distal portion of the instrument thatis configured to be located within the patient's body during use of theinstrument on a patient. In an exemplary embodiment, all of the one ormore instrument RF modules 214 can be attached along a longitudinal axisof the instrument and hence be positioned along a trajectory of theinstrument. The one or more RF modules 214 can thus be configured toprovide locational information of the instrument's trajectory. The oneor more RF modules 214 can be positioned anywhere along the instrument'slongitudinal axis. In an exemplary embodiment, the one or more RFmodules 214 can be attached along the instrument's longitudinal axis atan elongate shaft of the instrument that defines the instrument'slongitudinal axis and/or at a handle of the instrument.

In an exemplary embodiment, the instrument RF module(s) 214 can beattached to an exterior surface of the instrument. The instrument RFmodule(s) 214 can be attached to the exterior surface of the instrumentin a variety of ways, and can be attached thereto temporarily orpermanently. Temporarily attaching the instrument RF module(s) 214 tothe instrument can facilitate re-use of the instrument RF module(s) 214by allowing the instrument RF module(s) 214 to be removed from theinstrument after use of the instrument and subsequently attached toanother instrument. In this way, the instrument RF module(s) 214 can,but need not be, disposed of if attached to a one-time-use, disposableinstrument or of the instrument to which the instrument RF module(s) 214is attached to breaks and cannot be reused in a subsequent surgicalprocedure. The instrument RF module(s) 214 can be temporarily attachedto the instrument using any one or more attachment elements such as abiocompatible adhesive (e.g., a glue, etc.), Velcro®, etc. In oneembodiment, the instrument RF module(s) 214 can be temporarily attachedto an instrument by being included in a removable component of theinstrument, such as by being included in a handle configured to beremovably coupled to a remainder of the instrument (e.g., by beingthreaded thereon, by being snap fit thereon, etc.). The removablecomponent including the instrument RF module(s) 214 can thus be reusedwith various instruments, while the remainder of the instrument can bedisposed of. Permanently attaching the instrument RF module(s) 214 tothe external surface of the instrument can facilitate tracking of theinstrument by keeping the same instrument RF module(s) attached thereto.The instrument RF module(s) 214 can be permanently attached to theinstrument by being, e.g., welded to the instrument, adhered theretousing a permanent adhesive, etc.

In another exemplary embodiment, the instrument RF module(s) 214 can bepermanently embedded within an instrument. Embedding the instrument RFmodule(s) 214 can help protect the instrument RF module(s) 214 fromdamage by preventing the instrument RF module(s) 214 from being exposedto on the instrument's exterior surface where fluids, sharp objects,etc. could potentially damage the instrument RF module(s) 214. Theinstrument RF module(s) 214 can be embedded in the instrument a varietyof ways, as will be appreciated by a person skilled in the art, such asby being included within the instrument during manufacturing of theinstrument.

If a plurality of instrument RF modules 214 are attached to aninstrument, all of the instrument RF modules 214 can be temporarilyattached to the instrument, all of the instrument RF modules 214 can bepermanently attached to the instrument, or at least one of theinstrument RF modules 214 can be temporarily attached and at least oneof the instrument RF modules 214 can be permanently attached.

FIG. 11 illustrates one embodiment of a surgical instrument 156 havingfirst and second instrument RF modules 158 a, 158 b attached thereto.The instrument 156 illustrated in FIG. 11 includes an awl, but one ormore instrument RF modules can be attached to any type of surgicalinstrument, such as trocars, cannulas, drills, passing pins, cross pins,spinal surgical instruments (e.g., spinal disc preparing instrumentssuch as trials, spreaders, cobbs, etc.; retractors, inserters; etc.),etc. Although two instrument RF modules 158 a, 158 b are attached to theinstrument 156 in the illustrated embodiment, any number of instrumentRF modules can be attached to an instrument, as mentioned above. Thefirst instrument RF module 158 a is attached to an external surface of adistal tip 156 t of the instrument 156 along a longitudinal axis 156A ofthe instrument, and the second instrument RF module 158 b is attached toan external surface of an elongate shaft 156 s of the instrument 156along the instrument's longitudinal axis 156A. The RF modules 158 a, 158b in the illustrated are thus attached to the instrument 156 along atrajectory of the instrument 156 defined by the longitudinal axis 156A.

The instrument 156 also includes a notification unit 160 attachedthereto. The notification unit 160 includes a light located at proximaltip 156 p of a handle 156 h of the instrument 156. Being located at theinstrument's proximal tip 156 p can help the notification unit 160remain visible even when instrument 156 is in use in a surgicalprocedure, e.g., when the instrument 156 is at least partially disposedwithin a patient. The notification unit 160 can, however, be locatedelsewhere on the instrument 156 and can be in a form other than a light.The notification unit 160 can be configured to provide a notification ofthe instrument's trajectory relative to a predetermined trajectory. Thenotification unit 160 can be configured to provide a notification indifferent degrees of precision, as discussed further below. In theillustrated embodiment, the notification unit 160 is configured toprovide notification in three degrees of precision, each indicated by adifferently colored light. The at least three degrees of precision caninclude the instrument 156 being along the predetermined trajectory asshown by a green light, the instrument 156 being near but not along thepredetermined trajectory as shown by a yellow light, and the instrumentbeing far from the predetermined trajectory as shown by a red light.Green, yellow, and red are examples; the degrees of precision can beshown by other colors.

Referring again to FIG. 2, the pre-planning module 200 can be configuredto facilitate determination of the predetermined trajectory in a varietyof ways using at least the one or more patient RF modules 210 attachedto the patient. In general, the pre-planning module 200 can beconfigured to use the location(s) of the one or more patient RF modules210 attached to the patient to determine a trajectory of an instrumentto be advanced to a target surgical site. The one or more patient RFmodules 210 can be attached to the patient adjacent the target surgicalsite, as discussed further below, which can facilitate thisdetermination of the predetermined trajectory.

The pre-planning module 200 can be configured to determine thepredetermined trajectory using the one or more patient RF modules 210attached to the patient and the one or more instrument RF modules 212attached to the instrument. In an exemplary embodiment, the pre-planningmodule 200 can be configured to determine the predetermined trajectoryduring the surgical procedure, e.g., when the patient is in the OR orother surgical setting. After the one or more patient RF modules 210have been attached to the patient, a user of the instrument can positionthe instrument at a first trajectory relative to the patient. Theinstrument's position relative to the patient can be verified using oneor more confirmation mechanisms, as will be appreciated by a personskilled in the art, such as by taking one or more intra-operativefluoroscopy images. FIG. 12 illustrates an embodiment of a fluoroscopysystem 218 configured to gather real time images of a patient 220 in anOR or other surgical setting using a C-arm 222, as will be appreciatedby a person skilled in the art. Based on the verified position of theinstrument relative to the patient, the instrument's first trajectorycan be adjusted any number of times, with verifications of each adjustedtrajectory being taken as discussed above, until the instrument is at adesired trajectory relative to the patient.

Referring again to FIG. 2, the user can signal to the pre-planningmodule 200 that the instrument is at the desired trajectory. The signalcan be provided in any of a variety of ways, such as by the user orother personnel actuating an actuator that causes a signal to betransmitted to the pre-planning module 200. The actuator can have avariety of configurations, such as a pushable button on the instrumentor other object (e.g., a keyboard button, a button on a tablet computer,etc.), a flippable switch on the instrument or other object, avoice-activated module configured to actuated with a voice command, etc.

In response to the signal transmitted to the pre-planning module, thepre-planning module 200 can be configured to set the desired trajectoryas the predetermined trajectory. The pre-planning module 200 can beconfigured to set the predetermined trajectory in a variety of ways,such as by registering a location of the instrument at the desiredtrajectory using the one or more instrument RF modules 212 attached tothe instrument and the one or more patient RF modules 210 attached tothe patient. The location of the instrument can be registered in avariety of ways, as will be appreciated by a person skilled in the art,such as by each of the patient and instrument RF modules 210, 212transmitting an RF signal to the pre-planning module 200 in response toa query signal, e.g., an RF signal transmitted by the RF controller 216.The pre-planning module 200 can determine the instrument's spatialrelationship to the patient using any one or more techniques, such as byRFID triangulation, e.g., using an algorithm to localize the patient andinstrument RF modules 210, 212. The pre-planning module 200 can beconfigured to set or “lock in” the determined spatial relationship ofthe instrument relative to the patient as the predetermined trajectory.

In another exemplary embodiment, the pre-planning module 200 can beconfigured to determine the predetermined trajectory before commencementof the surgical procedure, e.g., before the patient is in the OR orother surgical setting. The instrument's position relative to thepatient thus need not be verified using one or more confirmationmechanisms, e.g., fluoroscopy, during performance of the surgicalprocedure, which can save time, reduce costs, reduce radiation exposureof the patient, and/or reduce radiation exposure of surgical personnel.

In one embodiment, the pre-planning module 200 can be configured to usethe one or more patient RF modules 210 attached to the patient and oneor more pre-operative images of the patient, e.g., CT image(s) of thepatient gathered by the CT scanning machine 152, that include thepatient RF module(s) 210 to determine the predetermined trajectorybefore commencement of the surgical procedure. The one or moreinstrument RF modules 212 attached to the instrument need not be used inthis embodiment of determining the predetermined trajectory. The one ormore patient RF modules 210 in this embodiment can include a singlepatient RF module 210 attached to a non-movable location within thepatient at a target surgical site, as discussed above. The pre-planningmodule 200 can be configured to predetermine the trajectory based on theknown location of the one patient RF module 210 attached to the patientat the target surgical site, e.g., on the target site as discussedabove. The location can be known in comparison to the pre-operativeimage(s), which can be scaled to facilitate the comparison. Thetrajectory determination can include a surgeon and/or other medicalpersonnel measuring a distance from the patient RF module 210, e.g.,graphically measuring the distance. The measured distance can be enteredinto a programmable interface on or otherwise coupled to the surgicalinstrument, and the interface can set the desired spatial relationshiprequired between the patient RF module 210 and the one or moreinstrument RF modules 212 to determine the trajectory. The trajectorydetermination can be geometric, based on establishing patientcoordinates and scale, and then superimposing the trajectory associatedwith optimal surgical outcome results, or by surgeon preferenceoverride, for a given surgical technique. As will be appreciated by aperson skilled in the art, various pre-operative planning softwaresolutions exist that can predetermine such a trajectory based on a knowntarget site such as image guidance software systems available fromBrainLab of Feldkirchen, Germany.

In another embodiment, the pre-planning module 200 can be configured todetermine the predetermined trajectory pre-surgery using the one or morepatient RF modules 210 attached to the patient and one or morepre-operative images of the patient, e.g., CT image(s) of the patientgathered by the CT scanning machine 152, that include the patient RFmodule(s) 210. The one or more instrument RF modules 212 attached to theinstrument need not be used in this embodiment of determining thepredetermined trajectory. The one or more patient RF modules 210 in thisembodiment can include a plurality of patient RF module 210 eachattached to a non-movable location within the patient next to a targetsurgical site, as discussed above, such as one patient RF module 210 oneach vertebra immediately adjacent to a target vertebra. Thepre-planning module 200 can be configured to predetermine the trajectorybased on the known location of the plurality of patient RF modules 210attached to the patient near the target surgical site, as known by thepre-operative image(s). As will be appreciated by a person skilled inthe art, various pre-operative planning software solutions exist thatcan predetermine such a trajectory based on a known target site, asdiscussed above.

The determination module 202 can be configured to determine whether theinstrument's trajectory is aligned with the predetermined trajectory ina variety of ways using the one or more patient RF modules 210 attachedto the patient and the one or more instrument RF modules 212 attached tothe instrument. In general, the determination module 202 can beconfigured to compare the instrument's trajectory to the predeterminedtrajectory so as to determine whether the trajectory matches thepredetermined trajectory. The determination module 202 can be configuredto store determined trajectory information in the procedure database208, which can facilitate review of the surgical procedure, e.g., forefficiency purposes.

The determination module 202 can be configured to compare the trajectorywith the predetermined trajectory in at least two degrees of precision.In this way, the determination module 202 can be configured to indicatevia the notification module 204 and the notification unit 210 one of atleast one of two different positions of the trajectory of the instrumentrelative to the predetermined trajectory. In an embodiment including twodegrees of precision, one degree of precision can indicate that theinstrument's trajectory is along the predetermined trajectory, and theother degree of precision can indicate that the instrument's trajectoryis not along the predetermined trajectory. In an exemplary embodiment,the determination module 202 can be configured to compare the trajectorywith the predetermined trajectory in at least three degrees ofprecision. Allowing at least three degrees of precision can allow thenotification to provide more specific information than the two degreesof “yes” or “no” as to whether the trajectory aligns with thepredetermined trajectory, which can help the trajectory be more quicklyand accurately adjusted to match the predetermined trajectory. The atleast three degrees of precision can include the instrument being alongthe predetermined trajectory, the instrument being near but not alongthe predetermined trajectory, and the instrument being far from thepredetermined trajectory. The notification can thus indicate whether theinstrument should be adjusted to match the instrument's trajectory tothe predetermined trajectory.

The determination module 202 can be configured to determine that thetrajectory matches the predetermined trajectory without any degree oferror, e.g., a 100% match. However, the determination module 202 can beconfigured to determine in a first degree of precision that thetrajectory matches the predetermined trajectory with an amount ofnegligible offset, similar to allowance of machine tolerances inmanufacturing parts. Allowing the amount of negligible error can betterallow the determination module 202 to ever determine a match, asnegligible offset may exist between the trajectory and the predeterminedtrajectory yet be substantially the same, as will be appreciated by aperson skilled in the art. The negligible offset can be pre-programmedinto the determination module 202 for each instrument used in a surgicalprocedure which includes one or more instrument RF modules, therebyallowing permissible negligible offset for each predetermined trajectoryto be specifically accounted for by the determination module 202.Alternatively, the negligible offset can be standardized for eachinstrument that includes one or more instrument RF modules, which canhelp save planning resources. The negligible offset can be, e.g., up toabout +/−2 mm from a starting point of the predetermined trajectory, upto about +/−1 mm from a starting point of the predetermined trajectory,up to about 2° away from a true center of the predetermined trajectory,up to about 1° away from a true center of the predetermined trajectory,etc.

The determination module 202 can be configured to determine in a seconddegree of precision that the trajectory is near but not along thepredetermined trajectory, e.g., is offset from the predeterminedtrajectory up to a certain amount of offset. The certain amount ofoffset can be pre-programmed into the determination module 202 for eachinstrument used in a surgical procedure which includes one or moreinstrument RF modules, thereby allowing permissible offset for eachpredetermined trajectory to be specifically accounted for by thedetermination module 202. Alternatively, the certain amount of offsetcan be standardized for each instrument that includes one or moreinstrument RF modules 214, which can help save planning resources. Thecertain amount offset can be, e.g., greater than the negligible offsetand less than about +/−4 mm from a starting point of the predeterminedtrajectory, greater than the negligible offset and less than about +/−3mm from a starting point of the predetermined trajectory, greater thanthe negligible offset and less than about 5° away from a true center ofthe predetermined trajectory, etc.

The determination module 202 can be configured to determine in a thirddegree of precision that the instrument's trajectory is far from thepredetermined trajectory, e.g., is offset from the predeterminedtrajectory over the certain amount of offset. The determination module202 can be configured to determine that the trajectory is offset fromthe predetermined trajectory over the certain amount of offset if theinstrument's trajectory is offset, e.g., greater than about +/−4 mm froma starting point of the predetermined trajectory, greater than about+/−3 mm from a starting point of the predetermined trajectory, greaterthan about 5° away from a true center of the predetermined trajectory,etc.

Although three degrees of precision are described above, thedetermination module 202 can be configured to compare the trajectory tothe predetermined trajectory in more than or less than three degrees.Each different degree of precision that the determination module 202 isconfigured to use can have a different range of offset. In other words,a first degree of precision can be within “A” offset, a second degree ofprecision can be greater than “A” offset but less than “B” offset, athird degree of precision can be greater than “B” offset but less than“C” offset, a fourth degree of precision can be greater than “C” offsetbut less than “D” offset, etc.

The determination module 202 can be configured to compare thepredetermined trajectory with a trajectory of the instrument having oneor more RF modules 214 attached thereto and for at least one additionalsurgical instrument used on the patient that has one or more instrumentRF modules 214 attached thereto. The predetermined trajectory determinedfor one instrument by the pre-planning module 200 can thus be used formultiple instruments without having to determine a predeterminedtrajectory for each of the different instruments.

The determination module 202 can be configured to cause the notificationmodule 204 to trigger the notification unit 210 to provide thenotification in at least two degrees of precision. If the notificationindicates that the instrument is along the predetermined trajectory,e.g., the determination module 202 determines that the trajectorymatches the predetermined trajectory, then the instrument can bemaintained in its current trajectory. If the notification indicates thatthe instrument is near but not along the predetermined trajectory, e.g.,the determination module 202 determines that the trajectory is offsetfrom the predetermined trajectory up to the certain amount of offset,the instrument can be slightly adjusted to align its trajectory with thepredetermined trajectory. In other words, a user of the instrument canbe notified that the instrument only needs slight adjustment to bealigned with the predetermined trajectory, which can help prevent theuser from overcorrecting to align with the predetermined trajectory. Ifthe notification indicates that the instrument's trajectory is far fromthe predetermined trajectory, e.g., the determination module 202determines that the trajectory is offset from the predeterminedtrajectory over the certain amount of offset, the instrument can beadjusted in a relatively aggressive manner to align its trajectory withthe predetermined trajectory. In other words, a user of the instrumentcan be notified that the instrument needs a relative large amount ofadjustment to be aligned with the predetermined trajectory, which canhelp prevent the user more quickly align the instrument's trajectorywith the predetermined trajectory than if the user was merely informedthat the instrument's trajectory is not aligned with the predeterminedtrajectory.

The determination module 202 can be configured to cause the notificationmodule 204 to trigger the notification unit 210 to provide a differentnotification for each of the different degrees of precision, e.g., adifferent sound for each degree of precision (e.g., one beep for a firstdegree, two beeps for a second degree, three beeps for a third degree,etc.; a chime for a first degree, a buzz for a second degree, a clickfor a third degree, etc.; and so forth), a different colored light foreach degree of precision (e.g., a green light for a first degree, ayellow light for a second degree, a red light for a third degree, etc.;no light for a first degree, a white light for a second degree, a redlight for a third degree, etc.; and so forth), a different lightillumination sequence for each degree of precision (e.g., one lightblink for a first degree, two light blinks for a second degree, threelight blinks for a third degree, etc.; a steady light for a firstdegree, a slowly blinking light for a second degree, a faster blinkinglight for a third degree, etc.; and so forth), different text digitallyshown on a display for each degree of precision (e.g., “no adjustmentneeded” for a first degree, “slight adjustment needed” for a seconddegree, “significant adjustment needed” for a third degree; and soforth), different vibration for each degree of precision (e.g., novibration for a first degree, slight vibration for a second degree,significant vibration for a third degree, etc.; and so forth), etc.

The determination module 202 can be configured to cause the notificationmodule 204 to trigger the notification unit 210 to provide only one typeof notification (e.g., one of sounds, light, vibration, text, etc.), orthe determination module 202 can be configured to cause the notificationmodule 204 to trigger the notification unit 210 to simultaneouslyprovide a plurality of types of notification (e.g., two or more ofsounds, light, vibration, text, etc.). Providing multiple types ofnotifications can help increase chances that the notification isdetected, e.g., seen, heard, and/or felt, by a user of the instrument,thereby increasing chances that the instrument's trajectory matches thepredetermined trajectory throughout use of the instrument.

In use, the system 100 can be configured to identify whether a surgicalinstrument being used in a surgical procedure on a patient has atrajectory relative to the patient that is aligned with a predeterminedtrajectory, and to provide notification of the trajectory's alignmentrelative to the predetermined trajectory. An embodiment of trajectoryidentification is discussed below with reference to an embodiment of asurgical procedure illustrated in FIGS. 13 and 14, the module 200, 202,204 of FIG. 2, the patient RF module 142 and the patient 154 of FIGS.8-10 and the instrument 156 and the instrument RF modules 158 a, 158 bof FIG. 11. However, any of the computer systems described herein can beconfigured to provide such trajectory identification, and the trajectoryidentification can be provided in connection with any of a variety ofsurgical procedures in which it is beneficial to advance a surgicalinstrument toward a patient at a particular approach angle, e.g., sothat the instrument accesses a target site at an angle from which theinstrument can perform its desired function, so that the instrument isinserted into the patient without damaging any patient's nerves, so thatthe instrument's trajectory matches a trajectory identified by a surgeonpre-surgery, etc.

The instrument 156 can be advanced toward the spine 146 of the patient154, as shown in FIG. 13. If a predetermined trajectory P has notalready been determined by the pre-planning module 200, thepredetermined trajectory P can be determined by the pre-planning module200, as discussed above. The determination module 202 can determinewhether a trajectory T of the instrument is aligned with thepredetermined trajectory P in any number of ways, as discussed above.The determination module 202 can determine that the trajectory T is notaligned with the predetermined trajectory P, as shown in FIG. 13. Thedetermination module 202 can thus not cause the light 160 to light up.In other words, the light 160 not being illuminated can indicate thatthe trajectory T is not aligned with the predetermined trajectory P. Thedetermination module 202 thus does not cause the notification module 204to trigger illumination of the light 160.

The instrument 156 can be adjusted in position relative to the patient154, with the determination module 202 repeatedly determining whetherthe trajectory T is aligned with the predetermined trajectory P. Therepeated determinations can be continuous, which can allow thenotification unit 410, e.g., the light 160, to provide continuouslyupdated trajectory information, thereby allowing the trajectory T to bereadjusted based on substantially real time information. Alternatively,the determination module 202 can be configured to repeatedly compare thetrajectory T with the predetermined trajectory P at predeterminedintervals, e.g., every 0.5 seconds, every one second, every two seconds,etc., which can help conserve processing resources of the system 10.When the determination module 202 determines that the trajectory T isaligned with the predetermined trajectory P, as shown in FIG. 14, thedetermination module 202 can cause the notification module 204 totrigger illumination of the light 160. The determination module 202 cancontinue monitoring the trajectory T relative to the predeterminedtrajectory P so as to change the notification, e.g., cause thenotification module 204 to turn off the light 160 or change the light160 to another color, if the trajectory T becomes misaligned from thepredetermined trajectory P. The predetermined trajectory P can bereadjusted any number of times during the surgical procedure, e.g., if asurgeon decides that another angular approach would be appropriate.

A person skilled in the art will appreciate that the present inventionhas application in conventional minimally-invasive and open surgicalinstrumentation as well application in robotic-assisted surgery.

The devices disclosed herein can also be designed to be disposed ofafter a single use, or they can be designed to be used multiple times.In either case, however, the device can be reconditioned for reuse afterat least one use. Reconditioning can include any combination of thesteps of disassembly of the device, followed by cleaning or replacementof particular pieces and subsequent reassembly. In particular, thedevice can be disassembled, and any number of the particular pieces orparts of the device can be selectively replaced or removed in anycombination. Upon cleaning and/or replacement of particular parts, thedevice can be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device can utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

The invention claimed is:
 1. A surgical method, comprising: non-movablyattaching a first radio frequency module to a patient at a firstlocation; positioning a surgical instrument relative to the patient, theinstrument having at least a second radio frequency module attachedthereto; taking an image of the patient and the surgical instrument toverify a position of the surgical instrument relative to the patient,said image including the first radio frequency module and the secondradio frequency module; receiving a signal from a user to set apredetermined trajectory based on the position of the surgicalinstrument; and advancing the surgical instrument towards the patientalong an actual trajectory while providing a notification to the user ofthe surgical instrument whether the actual trajectory of the surgicalinstrument is aligned with the predetermined trajectory.
 2. The methodof claim 1, wherein the first radio frequency module provides locationalinformation of a target site based on a distance from the first locationto the target site.
 3. The method of claim 2, wherein signaling furthercomprises actuating an actuator to transmit a signal that the surgicalinstrument is aligned with the predetermined trajectory.
 4. The methodof claim 2, further comprising comparing the actual trajectory of thesurgical instrument with the predetermined trajectory by determining aspatial relationship between the first radio frequency module and thesecond radio frequency module.
 5. The method of claim 1, whereinverifying a position of the surgical instrument relative to the patientfurther comprises comparing a location of the first radio frequencymodule to a location of the second radio frequency module in the image.6. The method of claim 1, wherein the actual trajectory is compared withthe predetermined trajectory as the surgical instrument is advancedtowards the patient.
 7. The method of claim 1, wherein the notificationis provided in at least three degrees of precision.
 8. The method ofclaim 1, further comprising changing a form of notification to the userwhen the actual trajectory is not aligned with the predeterminedtrajectory.
 9. The method of claim 8, further comprising adjusting theactual trajectory to align the actual trajectory with the predeterminedtrajectory.
 10. The method of claim 8, further comprising varying thenotification provided based on the amount of deviation between thepredetermined trajectory and the actual trajectory.
 11. The method ofclaim 1, wherein the actual trajectory is continuously compared with thepredetermined trajectory.
 12. The method of claim 1, wherein the actualtrajectory is compared with the predetermined trajectory at apredetermined time interval.
 13. The method of claim 12, wherein thepredetermined time interval is 0.5 seconds.
 14. The method of claim 1,wherein establishing the predetermined trajectory further comprisesregistering the position of the surgical instrument using the firstradio frequency module and the second radio frequency module.
 15. Themethod of claim 1, further comprising adjusting the position of theinstrument relative to the patient based on the image prior toestablishing the predetermined trajectory.
 16. A surgical method,comprising: positioning a surgical instrument relative to a patient;taking an image to verify a position of the surgical instrument relativeto the patient; locating a plurality of radio frequency modules in theimage, the plurality of radio frequency modules each being positioned ata non-movable location relative to the patient; adjusting the positionof the instrument relative to the patient based on the image; receivinga signal from a user to set a predetermined trajectory based on theposition of the surgical instrument; advancing the surgical instrumenttoward the patient along an actual trajectory; providing a notificationto a user of the surgical instrument whether the actual trajectory ofthe surgical instrument is aligned with the predetermined trajectory.17. The method of claim 16, wherein verifying a position of the surgicalinstrument relative to the patient further comparing a location of theplurality of radio frequency modules to the position of the surgicalinstrument in the image.
 18. The method of claim 17, further comprisingusing the locational information to set a spatial relationship betweenthe plurality of radio frequency modules and the surgical instrument.19. The method of claim 18, wherein the surgical instrument comprises anadditional radio frequency module, the additional radio frequency moduleconfigured to communicate with the plurality of radio frequency modules.20. The method of claim 19, further comprising comparing an actualtrajectory of the surgical instrument with the predetermined trajectoryby evaluating the spatial relationship between one or more of theplurality of radio frequency modules and the additional radio frequencymodule.
 21. The method of claim 20, further comprising continuouslyupdating the actual trajectory and comparing the actual trajectory tothe predetermined trajectory, the updated trajectory being determined bycomparing a location of the additional radio frequency module relativeto the one or more of the plurality of radio frequency modules.
 22. Themethod of claim 16, further comprising adjusting the actual trajectoryto align the actual trajectory with the predetermined trajectory. 23.The method of claim 16, wherein a plurality of notifications regardingwhether the actual trajectory is aligned with the predeterminedtrajectory are provided to the user.
 24. The method of claim 16, whereinthe plurality of radio frequency modules is implanted within thepatient.